U.S. patent number 9,492,187 [Application Number 11/685,522] was granted by the patent office on 2016-11-15 for minimally invasive surgical assembly and methods.
This patent grant is currently assigned to TELEFLEX MEDICAL INCORPORATED. The grantee listed for this patent is H. Allan Alward, Guy L. Osborne, Sundaram Ravikumar, Robert F. Smith, Steven J. Wysocki. Invention is credited to H. Allan Alward, Guy L. Osborne, Sundaram Ravikumar, Robert F. Smith, Steven J. Wysocki.
United States Patent |
9,492,187 |
Ravikumar , et al. |
November 15, 2016 |
Minimally invasive surgical assembly and methods
Abstract
A minimally invasive surgical assembly broadly includes an outer
hollow needle which has an outer diameter of 3.0 mm or smaller, and
a coaxial surgical instrument having a shaft which extends through
the outer hollow needle. The coaxial surgical instrument includes
end effectors at the end of the shaft which are biased to an open
position such that when the end effectors of the surgical
instrument extended out of the needle they open, and they are
closed by relative movement of the needle over them. The assembly
preferably includes a first fixing element which is used to fix the
relative location of the surgical instrument and the needle. The
assembly also preferably includes a second fixing element which
moves relative to the needle and is located on the outside thereof
and which is used to fix the relative location of the needle to the
patient.
Inventors: |
Ravikumar; Sundaram (Briarcliff
Manor, NY), Alward; H. Allan (Shelton, CT), Wysocki;
Steven J. (Stratford, CT), Osborne; Guy L. (Trumbull,
CT), Smith; Robert F. (Waterbury, CT) |
Applicant: |
Name |
City |
State |
Country |
Type |
Ravikumar; Sundaram
Alward; H. Allan
Wysocki; Steven J.
Osborne; Guy L.
Smith; Robert F. |
Briarcliff Manor
Shelton
Stratford
Trumbull
Waterbury |
NY
CT
CT
CT
CT |
US
US
US
US
US |
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Assignee: |
TELEFLEX MEDICAL INCORPORATED
(Morrisville, NC)
|
Family
ID: |
38510235 |
Appl.
No.: |
11/685,522 |
Filed: |
March 13, 2007 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20070250112 A1 |
Oct 25, 2007 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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11420927 |
May 30, 2006 |
7766937 |
|
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60781556 |
Mar 13, 2006 |
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60828916 |
Oct 10, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/00234 (20130101); A61B 17/3403 (20130101); A61B
90/57 (20160201); A61B 17/29 (20130101); A61B
17/3417 (20130101); A61B 90/50 (20160201); A61B
17/221 (20130101); A61B 2090/571 (20160201); A61B
2017/3407 (20130101); A61B 2017/3492 (20130101); A61B
17/122 (20130101); A61B 17/068 (20130101); A61B
2017/00353 (20130101); A61B 2017/2215 (20130101); A61B
2017/00349 (20130101); A61B 2017/347 (20130101); A61F
2/0063 (20130101) |
Current International
Class: |
A61B
17/28 (20060101); A61B 17/221 (20060101); A61B
17/34 (20060101); A61B 17/29 (20060101); A61B
17/068 (20060101); A61B 17/122 (20060101); A61B
17/00 (20060101); A61F 2/00 (20060101) |
Field of
Search: |
;606/205-207,167,170,185,190,193,194,139,142 ;604/164.01,106
;D24/143 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Severson; Ryan J
Assistant Examiner: Dang; Anh
Attorney, Agent or Firm: Baker Hostetler LLP
Parent Case Text
This application claims priority from U.S. provisional application
60/781,556 filed Mar. 13, 2006, and from U.S. provisional
application 60/828,916 filed Oct. 10, 2006, and is a
continuation-in-part of U.S. Ser. No. 11/420,927, now U.S. Pat. No.
7,766,937 all of which are hereby incorporated by reference herein
in their entireties.
Claims
What is claimed is:
1. A surgical assembly, comprising: a hollow needle having an outer
diameter of 3 mm or smaller and a sharp distal end; a first handle
coupled to a proximal portion of said hollow needle; a surgical
instrument having a shaft which extends through said hollow needle,
and having end effectors at a distal end of said shaft which are
biased to an open position; a plunger coupled to a proximal portion
of said shaft and coupled to said first handle, said plunger
constructed for longitudinal movement with respect to said first
handle; a second handle coupled to a proximal portion of said
plunger, wherein said surgical instrument is configured to move
relative to said hollow needle into a plurality of positions by
hand-manipulation that moves said second handle and said plunger
longitudinally relative to said first handle, wherein said
plurality of positions include a first retracted position, a second
open position and a third closed position, wherein said second
handle is free to rotate with respect to said first handle, said
hollow needle, and said plunger in at least said first retracted
position, said second open position, and said third closed
position, wherein in said first retracted position, said end
effectors are contained in said hollow needle proximal said sharp
distal end of said hollow needle and said sharp distal end of said
hollow needle is exposed such that it can be used to pierce,
wherein in said second open position, said end effectors extend out
of said hollow needle and said end effectors automatically open
relative to each other and said sharp distal end of said hollow
needle is protected by said end effectors, and wherein in said
third closed position, said hollow needle extends over said end
effectors, said end effectors are automatically forced into a
closed position by said sharp distal end of said hollow needle and
said sharp distal end of said hollow needle is protected by said
end effectors; and a safety mechanism establishing a predetermined
working range for said surgical instrument relative to said hollow
needle, wherein said predetermined working range, said end
effectors always extend past a tip of said sharp distal end of said
hollow needle, and said safety mechanism includes a stop body
biased to limit proximal movement of said surgical instrument
relative to said hollow needle beyond said predetermined working
range thereby preventing said surgical instrument from being moved
from said predetermined working range to said first retracted
position, wherein said stop body includes a member rotatably
biased, via a spring, towards a central axis of said plunger to
interface with said plunger in order to automatically limit
proximal movement of said surgical instrument relative to said
hollow needle beyond said predetermined working range, and wherein
said stop body includes a surface to interfere with said plunger to
lock a relative location of said surgical instrument with respect
to said hollow needle while said surgical instrument is within said
predetermined working range.
2. The surgical assembly according to claim 1, wherein said hollow
needle has an inner surface and said shaft has an outer surface,
and said outer surface and said inner surface are sized so that at
least a portion of said shaft closely slides against said inner
surface of said hollow needle, thereby forming a seal which is
effective against desufflation.
3. The surgical assembly according to claim 1, further comprising:
a fixing element coupled to and movable relative to said hollow
needle for fixing a relative location of said hollow needle to a
patient.
4. The surgical assembly according to claim 3, wherein said fixing
element comprises a suction cup extending around said hollow
needle.
5. The surgical assembly according to claim 3, wherein said fixing
element comprises a compressible ball joint mechanism.
6. The surgical assembly according to claim 1, wherein said hollow
needle is between 13 cm and 18 cm long.
7. The surgical assembly according to claim 1, wherein said end
effectors open to a distance between them of more than twice a
diameter of said hollow needle.
8. The surgical assembly according to claim 1, wherein said end
effectors are graspers having first portions coupled to said shaft
and extending substantially parallel to a longitudinal axis of said
shaft, second portions which angle away from said longitudinal axis
at between 6.degree. and 18.degree., and third portions which angle
back from said second portions toward said longitudinal axis.
9. The surgical assembly according to claim 8, wherein said third
portions are substantially parallel to said longitudinal axis.
10. The surgical assembly according to claim 1, wherein said hollow
needle has a sharpened end angled at substantially 35.degree..
11. The surgical assembly according to claim 1, wherein said
surgical instrument consists essentially of said shaft, said spring
biased end effectors which are rigidly coupled to said shaft at a
distal end of said shaft and at proximal ends of said end
effectors, said plunger and said second handle.
12. The surgical assembly according to claim 11, wherein said
hollow needle consists essentially of a hollow shaft having said
outer diameter of substantially 2 mm or smaller, said sharp distal
end, and the first handle.
13. The surgical assembly according to claim 12, wherein said
surgical assembly consists essentially of said hollow needle, said
first handle, said surgical instrument, and said safety
mechanism.
14. The surgical assembly according to claim 12, wherein said
surgical assembly consists essentially of said hollow needle, said
first handle, said surgical instrument, said safety mechanism, and
a fixing element for fixing said hollow needle relative to a body
cavity into which said sharp distal end is placed.
15. The surgical assembly according to claim 1, further comprising:
an override for said safety mechanism.
16. The surgical assembly according to claim 1, wherein said hollow
needle is beveled to a tip and said end effectors are graspers
having outer surfaces and inner grasping surfaces facing each
other, wherein said surgical instrument is fixed oriented relative
to said hollow needle so that more of an outer surface of a first
of said end effectors is exposed than an outer surface of a second
of said end effectors when said first and second end effectors
extend partially out of said hollow needle.
17. The surgical assembly according to claim 1, wherein said end
effectors comprise martensitic stainless steel, precipitation age
hardened with heat treatment.
18. The surgical assembly according to claim 1, wherein a
longitudinal groove is formed on said plunger, said longitudinal
groove having a stop surface at a distal portion of said plunger,
and wherein said longitudinal groove receives said member of said
stop body and said stop surface engages said member of said stop
body to limit proximal movement of said surgical instrument
relative to said hollow needle beyond said predetermined working
range.
19. The surgical assembly according to claim 18, further comprising
a rotational linkage between the second handle and said
plunger.
20. The surgical assembly according to claim 19, wherein said
plunger has a tubular opening formed in a proximal end of said
plunger, and said tubular opening receives a post of said second
handle.
21. The surgical assembly according to claim 20, wherein the post
has an annular groove formed therein, and said groove receives a
pin through a pin hole formed in said plunger to couple said second
handle to said plunger while permitting relative rotation
therebetween.
22. The surgical assembly according to claim 1, wherein said member
of said stop body includes a nose, and said stop body is rotatably
coupled to said first handle, wherein said plunger includes a
groove, and wherein the nose of said stop body and the groove of
said plunger interact with each other to limit proximal movement of
said surgical instrument relative to said hollow needle to prevent
said surgical instrument from being moved from said predetermined
working range back to said first retracted position.
23. The surgical assembly according to claim 22, wherein the groove
of said plunger has a flattened distal portion forming a stop
surface, wherein the nose has a bottom surface, and said stop body
is biased such that the bottom surface extends generally
perpendicular to an axis of said plunger, and wherein the stop
surface interacts with the bottom surface of said stop body to
limit proximal movement of said surgical instrument relative to
said hollow needle.
24. The surgical assembly according to claim 1, wherein said first
handle has an outer surface including a lower ribbed portion and an
upper ribbed portion, and wherein said first handle includes a
hourglass shaped waist between the lower ribbed portion and the
upper ribbed portion.
25. The surgical assembly according to claim 24, wherein the upper
ribbed portion includes an opening for housing said safety
mechanism.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates broadly to surgical instruments and methods
of their use. More particularly, this invention relates minimally
invasive surgical instruments incorporating a needle and a working
device which extends through and beyond the needle and which can be
retracted into the needle. The invention has particular application
to laparoscopic-type surgery, although it is not limited
thereto.
2. State of the Art
Over the last two decades, minimally invasive surgery has become
the standard for many types of surgeries which were previously
accomplished through open surgery. Minimally invasive surgery
generally involves introducing an optical element (e.g.,
laparoscope or endoscope) through a surgical or natural port in the
body, advancing one or more surgical instruments through additional
ports or through the endoscope, conducting the surgery with the
surgical instruments, and withdrawing the instruments and scope
from the body. In laparoscopic surgery (broadly defined herein to
be any surgery where a port is made via a surgical incision,
including but not limited to abdominal laparoscopy, arthroscopy,
spinal laparoscopy, etc.), a port for a scope is typically made
using a surgical trocar assembly. The trocar assembly often
includes a port, a sharp pointed element (trocar) extending through
and beyond the distal end of the port, and at least in the case of
abdominal laparoscopy, a valve on the proximal portion of the port.
Typically, a small incision is made in the skin at a desired
location in the patient. The trocar assembly, with the trocar
extending out of the port is then forced through the incision,
thereby widening the incision and permitting the port to extend
through the incision, past any facie, and into the body (cavity).
The trocar is then withdrawn, leaving the port in place. In certain
circumstances, an insufflation element may be attached to the
trocar port in order to insufflate the surgical site. An optical
element may then be introduced through the trocar port. Additional
ports are then typically made so that additional laparoscopic
instruments may be introduced into the body.
Trocar assemblies are manufactured in different sizes. Typical
trocar port sizes include 5 mm, 10 mm and 12 mm (available from
companies such as Taut and U.S. Surgical), which are sized to
permit variously sized laparoscopic instruments to be introduced
therethrough including, e.g., graspers, dissectors, staplers,
scissors, suction/irrigators, clamps, forceps, biopsy forceps, etc.
While 5 mm trocar ports are relatively small, in some circumstances
where internal working space is limited (e.g., children), it is
difficult to place multiple 5 mm ports in the limited area. In
addition, 5 mm trocar ports tend to limit movements of instruments
inside the abdominal cavity to a great extent.
Further, while laparoscopic surgery has reduced the trauma
associated with various surgical procedures and has concomitantly
reduced recovery time from these surgeries, there always remains a
desire in the art to further reduce the trauma to the patient.
One area of trauma associated with laparoscopic surgery identified
by the inventor hereof as being susceptible of reduction are the
scars which result from the trocar ports used. In many laparoscopic
surgeries, three or more trocar incisions are made. For example, in
laparoscopic hernia repair surgery, four trocar incisions are
typically made, with one incision for insufflating the abdomen and
inserting the optical device, two incisions for trocar ports for
inserting graspers therethrough, and a fourth port for passing a
stapler therethrough. Those skilled in the art and those who have
undergone surgical procedures recognize that even the 5 mm trocar
ports leave holes which must be stitched and which result in
scars.
A second area of trauma associated with laparoscopic surgery
identified by the inventor hereof as being susceptible of reduction
relates to trauma resulting from the manipulation (angling) of the
trocar ports required in order to conduct the surgery due to
inexact placement. Angling of the port can cause tearing at the
incision periphery.
Those skilled in the art will also appreciate that because of the
number of trocar assemblies and laparoscopic tools used in
laparoscopic surgery (most of which are disposable because of the
cost and complications associated with autoclaving), the cost of
laparoscopic surgery is high. Thus, there always remains a desire
in the art to provide lower cost laparoscopic tools.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide a minimally
invasive surgical assembly which reduces trauma to the patient
relative to presently used systems.
It is another object of the invention to provide a minimally
invasive surgical assembly which is simple and inexpensive relative
to presently used systems.
It is a further object of the invention to provide a minimally
invasive surgical assembly which utilizes a 3 mm or smaller
incision/port device.
It is also an object of the invention to provide a minimally
invasive surgical assembly which will not scar a patient.
It is an additional object of the invention to provide a minimally
invasive surgical assembly utilizing effective surgical instruments
which are inserted into a 3 mm or smaller port device.
It is still another object of the invention to provide a minimally
invasive surgical assembly with reduced number of parts.
In accord with these objects, which will be discussed in detail
below, a minimally invasive surgical assembly according to the
invention broadly includes an outer hollow needle which has an
outer diameter of substantially 2.5 mm (the term "substantially",
for purposes of this application meaning.+-.20%), and preferably a
diameter of 2.5 mm or smaller and a coaxial surgical instrument
having a shaft which extends through the outer hollow needle. The
coaxial surgical instrument includes end effectors at the end of
the shaft which are biased to an open position such that when the
end effectors of the surgical instrument extend out of the needle
they open, and they are closed by relative movement of the needle
over them. The assembly preferably includes a first fixing element
which is used to fix the relative location of the surgical
instrument and the needle. The assembly also preferably includes a
second fixing element which moves relative to the needle and is
located on the outside thereof and which is used to fix the
relative location of the needle to the patient. The second fixing
assembly may include an anchoring element which permits the needle
to be held at different angles relative to the patient.
According to an embodiment of the invention, the surgical
instrument and needle are sized to a very small controlled
clearance therebetween so that at least a portion of the shaft of
the surgical instrument slides against the inner surface of the
needle, thereby forming a seal which is effective against
desufflation.
According to another embodiment of the invention, the surgical
assembly includes a safety mechanism which prevents inadvertent
withdrawal of the end effectors of the surgical instrument totally
within the needle such that the needle tip will be "exposed" (i.e.,
will not have the end effectors extending slightly outward
therefrom). The safety mechanism preferably includes an override
means so that the assembly can be initially placed in an "armed"
position with the needle tip exposed for purposes of initial
puncture, as well as for purposes of re-arming.
The surgical assembly of the invention may be used during
laparoscopic surgery instead of using an extra trocar and
laparoscopic instrument. In particular, with the surgical
instrument (e.g., grasper) partially inserted in the needle (i.e.,
with the end effectors at least partially withdrawn inside the
needle) and optionally locked relative to each other by the first
fixing element, the needle is used to puncture the skin and advance
into the body (e.g., the abdomen). At a desired location (typically
under guidance of an already inserted scope), the movement of the
needle is stopped. The surgical instrument is then unlocked (if
previously locked) and advanced until the end effectors extend past
the needle and open to their neutral stress position. The needle
and surgical instrument may then further advanced until the end
effectors extend over a structure in the body. Then, with the
surgical instrument stationary, the needle is advanced relative to
the surgical instrument to force the end effectors closed, thereby
securely grasping the structure. The first fixing element may then
be used to fix the needle relative to the surgical instrument to
prevent release of the grasped structure. If desired, the needle
with the surgical instrument fixed relative thereto and grasping
the structure may be manipulated relative to the body wall (e.g.,
to lift, push, or otherwise move the structure). When the needle
(or the grasped structure) is in a desired location in the body,
the second fixing element is slid along the needle and into
engagement with the skin of the patient, thereby fixing the
grasping end effectors at a desired location in the body. At any
time, the grasped structure can be released by causing the first
fixing element to release the surgical instrument and then moving
the needle backward (proximally) relative to the surgical
instrument, thereby permitting the end effectors to reopen. The
surgical assembly can be pulled out of the body (preferably with
the surgical instrument first moved backward relative to the needle
to retract and close the end effectors and locate them inside the
needle) leaving just a small puncture mark which will often heal
without a scar.
The surgical assembly of the invention thereby accomplishes the
objects of the invention with a minimum number of parts and may be
used to replace expensive trocar assemblies and laparoscopic
instruments.
Additional objects and advantages of the invention will become
apparent to those skilled in the art upon reference to the detailed
description taken in conjunction with the provided figures.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an enlarged broken cross sectional view of a first
embodiment of the surgical assembly of the invention with the end
effectors of the surgical instrument in an open (advanced)
position.
FIG. 2 is an enlarged broken cross sectional view of a first
embodiment of the surgical assembly of the invention with the end
effectors of the surgical instrument in a closed (retracted)
position.
FIGS. 3A-3E are broken representations of five different fixing
element systems for fixing the shaft of surgical instrument
relative to the needle.
FIG. 4 is a representation of a first embodiment of an anchoring
element for fixing the location of the surgical assembly relative
to the patient.
FIGS. 5A and 5B are respective top and side views of another
embodiment of an anchoring element for fixing the location of the
surgical assembly relative to the patient.
FIG. 6 is a schematic view of another mechanism fixing the location
of the surgical assembly relative to the patient.
FIGS. 7A-7G are representations of seven different end effectors
for the surgical instrument of the invention.
FIG. 8A-8D are representations of a modified surgical instrument
having end effectors acting as an obturator, and with the end
effectors located in a-rest shielding position, a puncturing
position, an extended position, and a withdrawn position
respectively.
FIGS. 9A-9D are schematic diagrams showing the use of four surgical
assemblies of the invention being used for a hernia repair
operation.
FIG. 10 is a front view of a thumb hold of a surgical
instrument.
FIGS. 11A-11C are three views of a plunger which couples the thumb
hold and shaft of a surgical instrument.
FIGS. 12A-12B are perspective views of the inside and outside of
one half of a proximal housing.
FIGS. 13A-13B are perspective views of the inside and outside of a
second half of the proximal housing.
FIG. 14 is a perspective view of a lock mechanism for the surgical
instrument.
FIG. 15A-15B are perspective views of a needle hub and needle
tip.
FIGS. 16A-16E are transparent views of the safety/locking mechanism
with the plunger in a fully retracted position, a beginning
deployment position, a position just prior to reaching a safety
locking position, the safety locked position, and a working or
operating range position respectively.
FIG. 17 is a view of the distal end of the surgical assembly with
the end effectors assuming a safety position relative to the needle
tip.
FIGS. 18A-18B are partially transparent side and perspective views
showing the lock mechanism engaging the plunger in an unlocked
position.
FIGS. 19A-19B are perspective and side views of the proximal
portion of the assembly showing the lock mechanism engaging the
plunger in a locked position.
FIG. 20A is a perspective view of the complete assembly extending
through a second fixing element.
FIG. 20B is a perspective view of a proximal portion of the
assembly with only part of a housing shown.
FIGS. 21A-21D are an exploded view, an assembled view, a top view,
and a cross-sectional view of a third embodiment of the second
fixing means of the invention.
FIG. 21E is a bottom view of the body of FIGS. 21A-21D.
FIG. 21F is a perspective view of the squeezable ball of FIGS.
21A-21D.
FIG. 21G is a perspective view of the base of FIGS. 21A-21D.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
A minimally invasive surgical assembly 10 according to the
invention and as seen in FIGS. 1 and 2 broadly includes an outer
hollow needle 12 which has an outer diameter of substantially 2.5
mm (0.1 inches), and a coaxial surgical instrument 14 having a
shaft 15 which extends through the outer hollow needle. The needle
12 has a sharpened distal end 18 which is angled at about
35.degree. relative to a longitudinal axis of the needle, and a
proximal end having a knob or handle 20 for holding and
manipulation of the needle. The inside diameter of the needle is
substantially 2.0 mm (0.08 inches) and the wall thickness of the
needle is substantially 0.25 mm (0.01 inch). The needle is
typically between 10 and 30 cm long, and more typically between 13
and 18 cm long (although other sizes could be used, depending upon
the surgery involved, and typically larger for obese patients and
smaller for infants and small children), and is preferably made
from stainless steel, although other materials could be
utilized.
The coaxial surgical instrument 14 shown in FIGS. 1 and 2 is a
grasper type instrument and includes end effectors 22 at the distal
end of the shaft 15 and a handle or knob 24 at the proximal end of
the shaft. The end effectors 22 are formed so that they biased to
an open position as seen in FIG. 1, such that when the end
effectors 22 of the surgical instrument 14 extend out of the needle
12 they open, and when the needle extends over them as in FIG. 2,
they close. The end effectors 22 may be formed from the end of the
shaft 15 as described in U.S. Pat. No. 6,616,683 to Toth et al.
which is hereby incorporated by reference herein in its entirety,
or in any other desired manner such as by forming end effectors and
connecting them to the shaft. The shaft 15 of the surgical
instrument 14 must be long enough to permit the end effectors to
extend out of the needle as seen in FIG. 1. The surgical instrument
14 is preferably made from stainless steel, although other
materials could be utilized for all or part of the instrument
14.
More particularly, in one embodiment, where the surgical instrument
is to be used for grasping, (i.e., the end effectors are graspers
as shown, e.g., in FIGS. 1, 7A-7F, 8A-8D and 17), the graspers can
be formed from sixty percent cold reduction Custom 475
precipitation-hardenable martensitic stainless steel wire available
from Carpenter Specialty Wire Products, Orangeburg, S.C. The
stainless steel wire is described in U.S. Pat. No. 6,630,103 which
is hereby incorporated by reference herein in its entirety and
includes 9.0%-13.0% and more preferably 10.5-11.5% chromium,
5.0%-11.0% and more preferably 8.0%-9.0% cobalt, 7.0%-9.0% and more
preferably 7.5%-8.5% nickel, 3.0%-6.0% and more preferably
4.75%-5.25% molybdenum, 1.0%-1.5% and more preferably 1.1%-1.3%
aluminum, 1.0% and more preferably 0.005-0.05% titanium (maximum),
0.5% and more preferably 0.1% silicon (maximum), 0.75% and more
preferably 0.25% copper (maximum), 0.5% and more preferably 0.1%
manganese (maximum), 0.025% and more preferably 0.0025% sulfur
(maximum), 0.03% and more preferably 0.015% carbon (maximum), 1.0%
and more preferably 0.20% niobium (maximum), 0.04% and more
preferably 0.015% phosphorus (maximum), 0.03% and preferably 0.01%
nitrogen (maximum), 0.02% and preferably 0.003% oxygen (maximum),
0.01% and preferably 0.0015-0.0035% boron, and remainder iron. The
wire may be subject to an EDM procedure to form the end effectors
as approximately 1.8 mm graspers with teeth (e.g., as shown in FIG.
7G--169a, and FIG. 17--569) or other structures, and then subject
to precipitation age hardening heat treatment at typically
975.degree. F. for an hour. The resulting end effectors have a high
yield strength, typically in excess of 300,000 psi, with good
elongation and toughness. This provides a clinical advantage in
that when too much material is placed in the end effectors and the
end effectors are actuated, the jaws will neither crush the
material, nor fracture themselves, but will plastically deform.
According to one aspect of the preferred embodiment of the
invention, the surgical instrument 14 and needle 12 are sized so
that at least a portion of the shaft 15 of the surgical instrument
14 slides against the inner surface of the needle 12, thereby
forming a seal which is effective against desufflation. Thus, where
the inner diameter of the needle is 2.00 mm, the outer diameter of
the shaft 15 is approximately 1.99 mm (0.078 inches), or about 0.01
mm smaller than the inner diameter of the needle. This small
difference in diameters results in a sliding low clearance fit
which can be felt as a drag and which effectively acts as a seal
against desufflation. If desired, only a portion of the shaft be
sized to interferingly slide against the inner surface of the
needle. Alternatively, the needle may include an internal gasket or
seal or grease which seals against the outer diameter of the
shaft.
Turning to FIGS. 3A-3E, according to the preferred embodiment, the
assembly 10 of the invention includes a first fixing mechanism,
element, or system which is used to fix the relative location of
the surgical instrument 14 and the needle 12. In FIG. 3A, the first
fixing system 50 is shown to include notches 52 on the shaft 15 of
the surgical instrument 14, and a screw 54 which extends through a
threaded radial hole 55 in the needle 12 or its handle. When it is
desired to fix the surgical instrument 14 relative to the needle
12, the screw 54 is screwed (typically clockwise) into the needle
and into engagement with a notch 52. When it is desired to release
the surgical instrument 14, the screw 54 is unscrewed so that it is
no longer engaged in the notch. It will be appreciated that instead
of a screw 54 and a threaded radial hole 55, a spring loaded pin
which extends through a radial hole in the needle (or needle
handle) could be utilized to lock the surgical instrument 14
relative to the needle 12.
In FIG. 3B, a second fixing system 50' is shown to include radial
grooves 60 on the shaft 15 of the surgical instrument and a clip 61
having spring arms 62 (one shown), and a shaft 63. The shaft 63 of
the clip 61 extends through a wall of the needle or, more
preferably, its handle, and the spring arms 62 engage a radial
groove 64 on the shaft 15. When the shaft 15 of the needle is
pushed or pulled relative to the needle, the spring arms 62 spread
to permit movement of the shaft 15 past the clip 61. It will be
appreciated that if the spring arms 62 are sufficiently springy,
grooves are not required on the shaft 15 of the needle as the
spring arms 62 will firmly hold the shaft in position.
A third fixing system 50'' is seen in FIG. 3C and includes a
plastic screw 65 which extends around the shaft 15 of the surgical
instrument 14, and an inner thread 66 located on the handle or knob
20 of the needle 12. When it is desired to fix the surgical
instrument 14 relative to the needle 12, the screw 65 is screwed
into the threaded handle or knob needle 20 of the needle 12. The
plastic screw 65 and the inner thread 66 of the handle or knob 20
of the needle are sized to cause the plastic screw 65 to deform and
tighten around the shaft 15 when the screw 65 is screwed into the
thread 66, thereby fixing the locations of the needle 12 and
surgical instrument 14 relative to each other. When it is desired
to release the surgical instrument 14, the screw 65 is unscrewed
sufficiently to permit movement of the surgical instrument relative
to the needle. As will be appreciated by those skilled in the art,
the screw 65 may have a gripping member such as a head (not shown)
to help the practitioner apply torque.
FIG. 3D shows a fourth fixing system 50''' which includes a thumb
screw 70 and a handle portion 20 of the needle 12 which includes a
thread (not shown), and which is flexible or plastic. In
particular, the thumb screw 70 when screwed onto the handle portion
threads causes the handle portion to clamp down on the shaft 15 of
the surgical instrument 14 and lock the surgical instrument
relative to the needle.
A fifth fixing system 50''' is seen in FIG. 3E where a cam element
72 is rotatingly coupled to the needle handle 20' by a pin 73. When
in a first orientation, the cam element 72 permits a rear portion
15' of the shaft 15 of the surgical instrument 14 to move in an
uninhibited manner. When in a second orientation as shown in FIG.
3E, the cam element 72 engages the rear portion 15' of the shaft 15
and holds it fixed relative to the needle handle 20' and needle 12.
It will be appreciated that in addition to the fixing system 50'''
which is different the fixing systems of FIGS. 3A-3D, the needle
handle 20' and surgical instrument handle 24' are modified relative
to the handles 20, 24 shown in FIGS. 1 and 2 and FIGS. 3A-3D.
The assembly also preferably includes a second fixing element which
moves relative to the needle and is located on the outside thereof
and which is used to fix the relative location of the needle to the
patient. More particularly, as seen in FIG. 4, the second fixing
element is a soft plastic suction cup 80 which engages and is
frictionally slidable over the outer surface of the needle 12, and
which can be pressed against the abdominal wall of a patient to
cause a suction connection. If desired, the outer surface of the
needle 12 may be provided with mating elements such as bumps,
serrations, or grooves (not shown), and the suction cup 80 may be
provided with a reciprocal mating element (not shown) for engaging
the mating element of the outer surface of the needle 12 to more
strongly fix the location of the suction cup 80 relative to the
needle 12.
Turning to FIGS. 5A and 5B, a second embodiment of the second
fixing assembly is seen to include a plastic suction cup 80' having
a top proximal hole 82 and a plurality of bayonet-type grooves 84
through which the needle 12 can be maneuvered. The suction cup 80'
thereby permits the needle 12 to be held at different angles
relative to the patient.
In lieu of a suction cup, it is possible to fix the location of the
needle 12 and surgical instrument 14 relative to the patient by
using standard equipment and modifying the surgical assembly of the
invention slightly. Thus, as seen in FIG. 6, a standard multiheaded
clip 90 is provided which is fixed by a clamp 92 to the side of an
operating room table. The multiheaded clip 90 includes a malleable
metal rod 94 and a plurality of clip elements 96. The surgical
assembly 10 may then be held in a desired position relative to the
patient by providing the needle 12 or surgical instrument 14 with a
clip receiver or groove which may be located on the outside surface
of the needle handle or on the handle or knob of needle or surgical
instrument. Details of a presently preferred multiheaded clip can
be found in co-owned U.S. Ser. No. 11/668,169 filed Jan. 29, 2007
and entitled "Platform for Fixing Surgical Instruments During
Surgery".
As will be appreciated by those skilled in the art, the surgical
instrument 14 of the invention may take various forms. Thus, FIGS.
7A-7G show representations of seven different end effectors for the
surgical instrument of the invention (although others could be
utilized). FIG. 7A shows a detailed view of a grasper such as seen
in FIGS. 1 and 2. The grasper end effectors 101 include two arms
102 which extend from shaft 15, each of which is approximately 19
mm (0.75 inch) long. The arms are slightly rounded on their outer
peripheries in the same profile as the shaft 15, with each rounded
surface forming an arc of between forty-five and ninety degrees.
The first portions 104 (e.g., about 4 mm) of the arms are
relatively straight in their at rest open position. The middle
portions 106 of the arms 102 then angle away from each other (each
at between 6.degree. and 18.degree. from the horizontal) until they
extend approximately 7 mm apart from each other. In order to
provide a good spring load, the middle portions of the arms may be
reinforced with or formed from spring steel. The tips 108 (e.g.,
approximately 3 mm) of the arms are then bent back to parallel the
first portions 104. Their outer surfaces may also be flattened.
If desired, the grasper of FIG. 7A can be formed from a solid rod
or a tube of steel, by cutting the end of the tube in half to form
arms (e.g., via use of a laser or an EDM machine), further removing
material from the underside of each arm at the first portions 104,
and then bending the arms at the intersections of the first
portions 104 and middle portions 106, and at the intersections of
the middle portions 106 and tips 108.
FIG. 7B is a representation of lung clamp end effectors 111. The
lung clamp end effectors extend from the shaft 15 with arms 112
which terminate in loops 114 which define openings 115. While not
shown in detail in FIG. 7B, the arms 112 are similar to the arms of
the grasper of FIG. 7A in that they are slightly rounded on their
outer peripheries in the same profile as the shaft 15, include
first portions 116 which are relatively straight in their at rest
open position and middle portions 118 which angle away from each
other until they extend approximately 6 mm apart from each other.
The loops 114 are then bent back to parallel the first portions
116. In order to provide a good spring load, the middle portions of
the arms may be reinforced with or formed from spring steel.
FIG. 7C is a representation of hybrid end effectors 121 including
one grasper 122 and one lung clamp 123. The grasper 122 is
substantially as described above with reference to FIG. 7A, and the
lung clamp 123 is substantially as described above with reference
to FIG. 7B.
FIG. 7D is a representation of non-crushing clamping end effectors
131 including one grasper 132 and a rubber covered arm 133.
FIG. 7E is a representation of retractor end effectors 141. The
retractor end effectors 141 are formed from wire mesh elements 143
which at rest are substantially flat, but which are bent into an
arcuate shape when retracted into the needle.
FIG. 7F is a representation of a grasper similar to that of FIG.
7A. The primary differences between the grasper end effectors 151
of FIG. 7F and the grasper end effectors 101 of FIG. 7A are that
the arms 152 are each approximately 25 mm-35 mm (1-1.38 inch) long,
the middle portions 156 angle away from each other at about
50.degree. or 25.degree. from the horizontal. The tip portions 158
shown in FIG. 7F are approximately 12 mm long and bend back
slightly beyond being parallel to the first portions 154 so that
they are angled slightly toward each other. Alternatively, the tip
portions need not bend back beyond the parallel or even at all. If
the tip portions are not bent back, the tip portions may be
designed to open 15 mm-20 mm relative to each other.
FIG. 7G is a representation of a crushing grasper 161 shown in a
closed position within a needle 12. The crushing grasper 161 is
similar to the grasper 101 of FIG. 7A except that it is slightly
longer (approximately 22 mm long), and the tip portions 168 have
teeth 169a and have a rounded front 169b such that they present a
blunt almost hemispherical surface. When the end effectors 161 of
FIG. 7G are moved forward relative to the needle 12, they
preferably remain in a closed position until approximately half the
length of the arms 162 extend beyond the needle. Thus, as will be
discussed below, the end effectors of the surgical instrument 14
may act as an obturator relative to the needle to guard the needle
from causing accidental needle tip trauma.
The surgical assemblies of the invention may be used during
laparoscopic surgery instead of using extra trocars and
laparoscopic instruments. In particular, with the surgical
instrument 14 (e.g., grasper end effectors 111) partially inserted
in the needle 12 (i.e., with the end effectors withdrawn at least
partially inside the needle) and optionally locked relative to each
other by the first fixing element (e.g., fixing system 50), the
needle 12 is used to puncture the skin and advance into the body
(e.g., the abdomen). At a desired location (typically under
guidance of an already inserted scope), the movement of the needle
is stopped. The surgical instrument 14 is then unlocked (if
previously locked) and advanced until the end effectors 111 extend
past the needle 12 and open toward their neutral stress position.
The needle and surgical instrument may then further advanced until
the end effectors extend over a structure in the body. Then, with
the surgical instrument stationary, the needle is advanced relative
to the surgical instrument to force the end effectors 111 closed,
thereby securely grasping the structure. The first fixing element
or system (e.g., system 50) may then be used to fix the needle
relative to the surgical instrument to prevent release of the
grasped structure. If desired, the needle with the surgical
instrument fixed relative thereto and grasping the structure may be
manipulated relative to the body wall (e.g., to lift, push, or
otherwise move the structure). When the needle (or the grasped
structure) is in a desired location in the body, the second fixing
element (e.g., 80) is slid along the needle and into engagement
with the skin of the patient, thereby fixing the grasping end
effectors at a desired location in the body. At any time, the
grasped structure can be released by causing the first fixing
element to release the surgical instrument and then moving the
needle backward relative to the surgical instrument, thereby
permitting the end effectors to reopen. The surgical assembly can
be pulled out of the body (preferably with the surgical instrument
first moved backward at least partially relative to the needle to
retract and close the end effectors) leaving just a small puncture
mark which will often heal without a scar.
It is noted that because of the small diameter of the surgical
assembly, withdrawal of the needle assembly from the abdomen will
not cause desufflation, and should not require stitching to close
the wound. It is also noted that because of the small diameter of
the surgical assembly the elimination of a trocar port, the
surgical assembly can be easily moved in any direction (i.e., it
can be easily angled) during surgery.
The surgical assembly of the invention thereby accomplishes the
objects of the invention with a minimum number of parts and may be
used to replace expensive trocar assemblies and laparoscopic
instruments.
According to another aspect of the invention, as previously
mentioned, the tips of the end effectors of the surgical instrument
may be used to function as an obturator. Thus, as seen in FIGS.
8A-8D, a surgical assembly combining aspects seen in FIGS. 3E and
7G is shown, except that a spring 193 is provided and coupled to
the handles 20', 24' of the needle and surgical instrument
respectively. Spring 193, in an at rest position, causes the
rounded end effectors 161 to assume a position where the end
effectors extend out of the needle 12 but remain in a closed
position as seen in FIG. 8A. In this partially extended position,
the end effectors 161 act as an obturator or protection from
accidental needle tip trauma. When the surgical assembly is used to
puncture skin as seen in FIG. 8B, pressure is placed on the end
effectors, thereby causing the end effectors 161 to be pushed back
into and thereby exposing the needle, and causing the surgical
instrument to move backward relative to the needle, thereby placing
spring 193 under tension. When the skin is punctured and the needle
extends into a cavity and pressure on the end effectors is
released, the spring 193 pushes the surgical instrument forward to
reassume the position of FIG. 8A. When it is desired to extend the
end effectors 161 to grasp a structure, the surgical instrument may
be pushed forward relative to the needle as seen in FIG. 8C,
thereby placing the spring 193 under compression, and opening the
end effectors 161. The end effectors may then be closed over the
object by pulling end effectors backward relative to the needle
whereby the needle acts on the end effectors to at least partially
close them, with the spring 193 assuming a partially compressed
position. The grasping position (and any other position) may be
locked at any time using the fixing element (e.g., cam 72). If it
is desired to pull the end effectors totally into the needle as
seen in FIG. 8D, that may be accomplished by pulling the surgical
instrument backward relative to the needle, again placing the
spring 193 in tension. The surgical instrument can be locked in
that position using the fixing element.
Use of a plurality of surgical assemblies 10a-10d is seen in FIGS.
9A-9D with respect to a hernia repair operation. In particular, an
abdominal wall 200 is seen with a hernia (opening) 290. The hernia
290 is to be repaired with mesh 290 which has been inserted into
the abdomen under guidance of a laparoscope (not shown). As seen in
FIG. 9A, four surgical assemblies 10a-10d according to the
invention have been used to pierce the abdominal wall. The four
assemblies 10a-10d are then used to grasp corner areas of the mesh
295 by moving the grasper end effectors out of their respective
needles and over and around the mesh corners, and by moving the
needles forward relative to the grasper instruments to force the
end effectors closed over the mesh. The needles and surgical
instruments are then preferably locked relative to each other
(using first fixing mechanisms or systems such as discussed above
with reference to FIGS. 3A-3E), and the assemblies 10a-10d are
pulled upward to cause the mesh 295 to lie directly below the
hernia 290 as seen in FIG. 9B. The assemblies are then preferably
locked in place relative to the abdominal wall using mechanisms
such as discussed above with reference to FIGS. 4, 5A, 5B, and 6.
Then, using a laparoscopic stapler (not shown) typically introduced
through a standard trocar port, the mesh is stapled in place. The
mesh may then be released by the assemblies 10a-10d by unlocking
the surgical instruments, unlocking the second fixing mechanisms,
and moving the respective needles backward in order to open the end
effectors. After the mesh is released, the end effectors of the
surgical instruments are withdrawn at least partially into the
needles (and optionally locked in place), and withdrawn from the
abdomen, leaving the mesh 295 stapled in place as seen in FIGS. 9C
and 9D.
It will be appreciated by those skilled in the art that the
minimally invasive surgical assemblies of the invention can be used
for various other surgical procedures, including but not limited to
tuboplasty, gastric bypass, bowel connection, kidney surgery,
appendectomy, menisectomy, discectomy, etc. The minimally invasive
surgical assemblies of the invention also have particularly
advantageous use in neonatal and pediatric surgeries, and the
assemblies and methods can be used on animals or cadavers.
Another embodiment of the surgical assembly of the invention is
shown in FIGS. 10-20B. As seen in FIGS. 20A and 20B, the assembly
510 includes a needle 512 and a medical instrument 514. The needle
has a sharpened distal tip 518 and a handle 520. The medical
instrument has end effectors 522 and a handle 524. Also shown in
FIGS. 20A and 20B is a lever 554 of a safety lock mechanism 550
which also serves as a first fixing mechanism. Seen in FIG. 20A is
a second fixing assembly 800 discussed hereinafter with reference
to FIGS. 21A-21G. Details of the needle 512, the medical instrument
514, and the safety lock mechanism 550 and the functioning of the
safety lock mechanism are seen in FIGS. 10-20B.
The handle 520 of the medical instrument is seen in FIG. 10. Handle
524 includes a loop 601 which is sized to receive the thumb of a
practitioner and a post 603 which extends in a direction parallel
or coaxial with the shaft of the instrument 514. The post 603 may
be provided with a seat 605 which can be used to receive a pin 607
(FIG. 16D) which will fix the handle 520 relative to the remainder
of the medical instrument 514 as discussed below.
The post 603 of the handle 524 is received in a plunger 610 shown
in FIGS. 11A-11C. More particularly, plunger 610 is a cylindrical
member having a head 611 and defining a top tubular opening 612, a
pin hole 613, a bottom tubular opening 614, a shaft surface 615
defining a first groove 616 which stops at a stop surface 617, a
second groove 618, a flattened distal portion 620 which helps
define a stop surface 621 for groove 618, and a bevel 622. The top
opening 612 receives the post 603 of the handle 520, and a pin 607
(FIG. 16D) is inserted in pinhole 613 so as to engage the seat 605
of the post 603. The pinhole 613 is eccentric relative to the post
603 so that it engages seat 605 and fixes the handle 524 axially
relative to the plunger 610, but permits the handle 524 to rotate
relative to the plunger. The bottom tubular opening 614 is provided
for receiving the shaft 515 of the medical instrument (the top
portion of which is shown only in FIG. 11B). If desired, the
plunger 610 can be formed as a cylinder with a single passageway
defining openings 612 and 614.
The grooves 616 and 618 defined in the shaft surface 615 of the
plunger 610 are used to perform several functions. As will be
described in more detail hereinafter, groove 616 is used to fix the
orientation of the end effectors 522 of medical instrument 514
relative to the bevel of the tip of the needle 512. The stop
surface 617 at the end of groove 618 also prevents the medical
instrument 514 from being completely removed from the needle 512.
Groove 618, together with flattened portion 620, stop surface 621,
and bevel 622 work together with lever 554 (FIGS. 14 and 20) to
provide a safety lock and a first fixing means 550 for the assembly
500.
Turning now to FIGS. 12A, 12B, 13A, and 13B, the handle 520 for the
needle is seen. The handle 520 is preferably formed from two
similar mating parts 520A, 520B which when mated together form
generally a spool-shaped handle. As seen in FIGS. 12A and 12B,
handle portion 520A includes four internal mating posts 622A, a
rotation post 624A, a spring catch or notch 625, a location tongue
626, plunger locating ribs 628A, a needle hub locating rib 629A and
a needle shaft locating rib 630A. Portion 520A also has an outer
surface with lower and upper ribbed portions 632A, 634A, a smooth
hourglass shaped waist 636A therebetween, with the lower ribbed
portion 632A defining an opening 638A for the needle shaft, and the
upper ribbed portion 634A defining an opening 639A for the plunger.
The upper ribbed portion 634A also defines an opening 640A for the
lever 554 as will be discussed hereinafter with a stop surface
641A. As seen in FIGS. 13A and 13B, handle portion 520B generally
corresponds to handle portion 520A, and with four internal mating
post receivers 622B, a rotation post receiver 624B, plunger
locating ribs 628B, needle hub locating rib 629B with locating
notch 629B1, and a needle shaft location rib 630B. Portion 520B
also has an outer surface with lower and upper ribbed portions
632B, 634B, a smooth hourglass shaped waist 636B therebetween, with
the lower ribbed portion 632B defining an opening 638B for the
needle shaft, and the upper ribbed portion 634B defining an opening
639B for the plunger. The upper ribbed portion 634B also defines an
opening 640B for the lever 554 with a stop surface 641B as will be
discussed hereinafter.
Lever 554 is seen in FIGS. 14, 18A and 18B, and includes a concave
ribbed friction surface 644, a body 646 defining a hole 647 and a
spring seat 648 (seen in FIG. 18A) for housing a spring 649, and a
nose 650. The hole 647 is sized to receive the rotation post 624A
such that the lever 554 can rotate about the post. The nose 650 is
generally triangular in shape with an angled top surface 650A and a
straight bottom surface 650B and has a first width which permits
the nose 650 to ride in groove 618 of the plunger. The body 646 has
a second larger width which is sized to fit within an opening into
the handle formed by openings 640A, 640B. As will be discussed
hereinafter, the rounded portion 652 of the body adjacent the top
of the nose is used as the first fixing element for the assembly.
The friction surface 644 has a preferably a third even larger width
and is located outside the mating parts 520A, 520B of the
handle.
Turning now to FIGS. 15A and 15B, the proximal and distal portions
of the needle 512 are seen. More particularly, as seen in FIG. 15B,
the distal tip 518 of the hollow needle is beveled and sharp. As
seen in FIG. 15A, the proximal end of the hollow needle 512 is
provided with a hub 655 with a boss 656. As indicated by FIG. 20B,
the hub 655 is sized to be captured in a hole formed by the needle
hub receiving ribs 629A and 629B, with the boss 656 received in the
cutout 629B1 so as to orient the needle bevel in a desired
orientation relative to the handle 520. If desired, the proximal
portion of the needle shaft may be textured to provide an extra
gripping surface for the practitioner.
Prior to discussing the functioning of the plunger 610 and lever
554, a couple of additional aspects of the invention are worth
noting. First, the spring seat 648 (FIG. 18) and spring catch or
notch 625 (FIG. 12A) are arranged to cause the spring 649 to bias
the lever 554 in a clockwise direction into a position where the
nose 650 is substantially perpendicular to the perpendicular axis
of the plunger 610 and needle 512. Rotation of the lever 554
clockwise from that position is stopped by the surface 641A, 641B
of the upper ribbed portions of the spool. Rotation of the lever
554 counterclockwise, against the spring can be accomplished easily
by applying a small amount of counterclockwise force to the lever
554. Second, while grooves 616 and 618 are shown in FIGS. 11A-11C
to be one hundred eighty degrees apart, they are more preferably
ninety degrees apart, and their actual locations must be considered
in conjunction with the location of pin 624A (FIG. 12A) which sets
the position of the lever 554 and the tongue 626 (FIG. 12A) which
rides in groove 616. Third, the orientation of the needle 512
through the use of the needle hub 655 and nub 656 (FIG. 15A) and
the needle hub receiving ribs 629A, 629B and locating notch 629B1
is preferably selected relative to the orientation of the end
effectors of the surgical instrument 514 (which are fixed relative
to the plunger 610) so that the end effectors present themselves in
a shielding manner relative to the bevel tip 518 of the needle 512.
In particular, according to one aspect of the invention, it is
desirable for the end effectors 518 to present as shown in FIG. 17
with the full, typically rounded outer surface 518 of one end
effector resting along the very tip 599 of the bevel edge of the
needle as opposed to the being rotated relative thereto. In this
manner the surface 518 of the end effector effectively continues
and/or rounds the beveled surface of the needle, i.e., it acts as
an internal shield so that the exposure of the sharpness of the
needle is significantly reduced. Fourth, if desired, the distal
portion of the plunger 610 (including the flattened portion 620)
may be colored with a red or other pigment (not shown) so that it
is highly visible as discussed hereinafter.
The functioning of the plunger 610 and the lever 554 in order to
provide a safety locking function and a first fixing function is
understood best with reference to FIGS. 16-19. More particularly,
FIG. 16A shows the positions of the plunger 610 and the lever 554
when the assembly in an "armed" position with the medical
instrument 514 fully retracted relative to the needle 512 so that
the needle tip 518 is not guarded by the end effectors. In the
position of FIG. 16A, the tongue 626 (FIG. 12A) of the spool
engages the stop surface 617 (FIGS. 11B and 11C) of the plunger
610. Also, in the position of FIG. 16A, the nose 650 of the lever
554 either doesn't engage the plunger 610 at all, or engages the
beveled end 622 of the plunger. In this armed position, the
assembly 510 (and in particular the needle 512) can be used to
puncture the skin of a patient so that the distal end of the
assembly can pass into a body cavity (e.g., the diaphragm). Also,
in this position, the distal portion of the plunger 610 extends out
of the needle handle 520. If this portion of the plunger is made
highly visible with coloration, the practitioner is given a
viewable warning that the assembly is armed (i.e., the needle is
unshielded).
After passing through the skin layers, it is desirable to move the
surgical instrument 514 forward so that the end effectors will
protect (guard) the bevel of the needle. As seen in FIG. 16B, as
the plunger 610 of the surgical instrument 514 is moved forward
relative to the needle, the bevel 622 of the plunger works against
the angled top surface 650A or the nose 650 of the lever 554 such
that the lever 554 rotates counterclockwise against the spring 649
(FIG. 18A). Further movement of the plunger 610 (FIG. 16C) causes
the nose 650 to ride in the flattened distal portion 620 of plunger
610 as the end effectors start to emerge from the back of the
bevel. When the plunger 610 is moved a little further as seen in
FIG. 16D, the nose 650 reaches the groove 618 and the top angled
surface 650A of the nose is no longer contacted by the plunger 610.
As a result, the spring 649 rotates the lever clockwise until the
bottom surface 650B of the nose 650 is generally perpendicular to
the axis of the plunger 610 and the nose 650 rides in groove 618.
As seen in FIG. 16D, if at this point an attempt is made to retract
the surgical instrument from the needle, the flat surface 650B of
the nose hits the stop surface 621 of the groove 618 and prevents
such movement; i.e., the assembly is in a safety position. When in
this safety position, the end effectors extend beyond the very
distal tip of the bevel of the needle 512 and guard the tip of the
needle as shown in FIG. 17. The only manner of withdrawing the end
effectors in order to rearm the needle is to override the stop by
manually forcing the lever clockwise, thereby pushing the plunger
610 slightly forward and permitting the nose to ride again in
flattened area 620.
Once the assembly has reached the safety position, the operator is
free to move the plunger up and down within the operating range of
the assembly to cause an opening and closing of the end effectors
(as discussed with reference to the previous embodiments of the
invention). The operating range is defined by the stop position of
FIG. 16D and a position where the top surface of the handle 520 of
the needle 512 abuts the head 611 of the plunger 610 of the
surgical instrument 514. FIG. 16E shows the assembly in an
operating range with the nose 650 of the lever located in the
groove 618.
At any point in the operating range of the assembly, the relative
location of the instrument 514 and the needle 512 can be fixed or
locked. This is accomplished by rotating the lever 554 clockwise
against the spring force until the rounded portion 652 of the body
646 of the lever adjacent the top of the nose 650 (which is wider
than the nose 650 and the groove 618) frictionally engages the
shaft surface 615 of the plunger 614 about the groove 618 as seen
in FIGS. 19A and 19B. The frictional forces of this engagement are
arranged to be greater than the spring force of spring 649 so that
spring 649 does not automatically disengage rounded portion 652
from the surface 615, and preferably large enough to prevent
inadvertent movement of the instrument relative to the needle. With
this arrangement, large tensile loads applied to the end effectors
relative to the needle may result in slippage of the locking
mechanism, and large compressive loads can cause unlocking. In
normal utilization, if it is desired to unlock the instrument from
the needle, the lever 554 may be rotated counterclockwise so that
the assembly can be used in its operating range. As with the other
embodiments of the invention, removal of assembly 510 from a body
can be accomplished with the end effectors opened or closed.
Turning now to FIGS. 21A-21G, a third embodiment of a second fixing
means is seen for fixing the surgical assembly relative to the body
of the patient. The second fixing means 800 includes three
elements: a base 810, a compressible ball 820 and an actuating body
830. The base 810 of the second fixing means 800 seen best in FIGS.
21A, 21D and 21G is essentially a washer, having a flat bottom
surface 832 to which an adhesive layer 834 (and a peelable
protective paper layer--not shown) may be applied, a frustroconical
central opening 836 (see FIG. 21D), and a top surface 838 which
defines finger grips 841 and a central ring 844. Ring 844 defines a
slightly tapered inner surface 845 (FIG. 21D) for receiving the
ball and three separate outer ramps 846 which are recessed into the
ring and start at the top surface 847 of the ring and descend as
they extend clockwise about the ring until they reach the top
washer surface 838. As seen best in FIG. 21G, the ramps 846 are
slightly recessed relative the openings on the top surface 847 of
the ring to form small ledges 848 for purposes explained
hereinafter.
The ball 820 is a preferably hollow plastic ball and is provided
with opposite circular openings 851, 852 sized to closely receive
the needle shaft of the surgical assembly 510, and a plurality of
slits 853 which extend about 120.degree. from the opening 852 in
the direction of the axis defined by openings 851, 852. With the
slits 853, the ball is compressible such that if a circumferential
force is applied to the ball, the lobes 854 formed between the
slits 853 will move toward each other. As seen best in FIGS.
21A-21D, the ball 820 is oriented in the ring 844 so that the slits
853 extend downward.
The actuating body 830 is seen best in FIGS. 21A and 21E and is
effectively comprises a cap 860 with extending arms 862. The cap
860 has a top wall 864 with a central opening 865 through which the
top portion of the ball 820 can extend. The cap 860 also has a side
wall 866 with cut-outs which define engagement fingers 868. The
engagement fingers 868 have bosses 869 which are sized to ride in
the ramps 846 of the ring 844. As seen best in FIG. 21E, the inward
facing bosses are ramped or beveled.
In assembly, the ball 820 is placed between the actuating body 830
and the base 810, and the bosses 869 are forced over the ledges 848
and into engagement with the ramps 846. In this position the bottom
of the side wall 866 of the cap 860 of the actuating body is spaced
relative to the top surface 838 of the washer (see FIG. 21D), and
the ball is free to rotate as guided by the ring 844 and central
opening 865. Thus, when a shaft of the surgical assembly is
inserted through the circular openings 851, 852 of the ball, the
shaft will have considerable freedom of movement, limited only by
the size of the central opening 865 of the cap 860 and the
frustroconical central opening 836 of the base. Preferably, the
second fixing means 800 provides the assembly with a freedom of
movement of at least forty-five degrees relative to the vertical in
all directions. However, when the actuating body 830 is rotated
clockwise relative to the base 810 (typically by squeezing arms 862
and 841 together with a thumb and forefinger), the bosses 869 ride
down the ramps 846 and pull the body 830 closer to the base 810.
Because the ball 820 cannot move downward in the ring, the central
opening 865 provides a circumferential force to the ball (i.e., it
compresses the ball), thereby forcing the lobes 854 inward, and
applying friction to the shaft of the surgical assembly. As a
result, not only is the shaft locked in place in the ball 820, but
the ball is fixed in its rotational orientation in the fixing means
800. The ball 820 and shaft may be released by rotating the body
830 counterclockwise relative to the base (typically by squeezing
the other arms 862, 841 together). The body 830, however, cannot
lift of the base 810 because the ledges 848 act as stops.
There have been described and illustrated herein several
embodiments of a minimally invasive surgical assembly and methods
its use. While particular embodiments of the invention have been
described, it is not intended that the invention be limited
thereto, as it is intended that the invention be as broad in scope
as the art will allow and that the specification be read likewise.
Thus, while particular materials for making the needle and surgical
instrument have been disclosed, it will be appreciated that other
materials may be used as well. In addition, while particular fixing
elements and systems have been disclosed for fixing the surgical
instrument relative to the needle, it will be understood that other
mechanisms can be used. For example, and not by way of limitation,
a latch-catch system can be used. Also, while particular fixing
elements and systems for fixing the location of the surgical
assembly relative to the patient have been described, it will be
recognized that other mechanisms can be used for that as well.
Furthermore, while particular end effectors such as graspers, lung
clamps, etc., have been described for the surgical instrument, it
will be understood that instruments with different end effectors
such as (but not limited to) dissectors, staplers, scissors,
suction/irrigators, clamps, biopsy forceps, etc., can be similarly
used. Also, the arms of the end effectors need not be of equal
length. Further, while the surgical instrument and needle have been
shown as being straight, because of their small diameter they may
be bent together by the user, or one or both may be formed with a
bend (arc). Moreover, while particular configurations have been
disclosed in reference to the handles of the surgical instrument
and the needle have been disclosed, it will be appreciated that
other configurations could be used as well. In addition, while the
needle was described as being a particular size and having a sharp
end with a certain angle, it will be appreciated that other size
needles can be used and the sharp can be at different angles. It
will therefore be appreciated by those skilled in the art that yet
other modifications could be made to the provided invention without
deviating from its spirit and scope as claimed.
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